Washington Drug Letter

BALTIMORE — Proposed language redefining current good manufacturing practices (cGMP) included in both versions of omnibus FDA user fee legislation appears to give the agency new authority to require drugmakers to make supplier quality agreements, a compliance expert says.

The House appropriations subcommittee that oversees FDA funding recommends fiscal 2013 appropriations that would slightly reduce agency spending.

Pharma stakeholders are calling on the FDA to publish a list of critical drugs to help clarify what products fall under current requirements and possible future laws for drug shortage notification.

BALTIMORE — Despite recurring pharma quality problems, drugmakers are still inclined to meet minimum manufacturing standards set by regulators, rather than make quality central to their business model.

Pharma companies seeking approval for drugs along with companion diagnostics could see quicker FDA decisions as the agency moves toward a stricter preapproval path for the diagnostic portion of companion products.

BALTIMORE — Drug shortages, poor product quality, poor corrective actions and other “manufacturing breakdowns” have conspired to create a crisis state that demands not only strong regulatory enforcement, but also active collaboration among drugmakers, FDA officials say.

The FDA has revised its guidance on testing a new drug’s genotoxicity to help drugmakers optimize the standard genetic toxicology battery and better predict potential human risks.

A class action lawsuit that presented FDA Form 483 inspection reports to allege that KV Pharmaceutical made false or misleading statements regarding its regulatory compliance can proceed even though inspection reports are not final agency determinations, an appeals court ruled.

The FDA has handed Merck a complete response letter on Taltorvic, a potential maintenance treatment for metastatic soft-tissue and bone sarcomas, calling for additional clinical trials to assess safety and efficacy.